The TGA currently only regulates manufactured devices. It has issued a consultation paper on the process of 3D printing bespoke bone implants, but Mr d'Urso is worried the Australian regulator will wait for the powerful US Food and Drug Administration to move first.

Ms Heller found Anatomics online and crowd-funded the operation. Mr d'Urso says Anatomics is 3D printing between 20 and 40 skull and bone implants each week, but needs regulatory approvals to get funding and deals with hospital groups to scale up.

Health minister Greg Hunt, then the Minister for Industry, Innovation and Science, is given a tour of 3D printing company Anatomics by the company's founder Paul D'Urso. Photo by Jesse Marlow. .
Jesse Marlow

Hospitals can make the implants on their own premises without the need for transport, storage and sterilisation, saving as much as 80 per cent on the cost of traditionally manufactured implants and providing a better match for patients, he said.

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Oz opportunity to write rules

But Mr d'Urso fears the FDA is being lobbied by large US medical device manufacturers that want to slow the regulatory approvals process for 3D printed implants. By contrast, he says China and India - large potential markets for Anatomics - want to progress the technology.

"If we don't do it they'll leapfrog us. They are doing it already," Mr d'Urso said. "It's where Australia has an opportunity to write the rules of the game."

Mr d'Urso, who has funded the business from private resources to date, is talking to private healthcare groups and government agencies about funding and deals to scale up the business.

Innovation and Science Australia chairman Bill Ferris cites the company as an example of the type of innovative company Australia needs more of to grow jobs through the commodity cycle.

Mr Ferris says in a speech on Friday that Anatomics' plan to expand via "a distributed business model through a network of 3D printers owned and operated in accredited hospitals here and abroad".

"Paul's software and designs will be downloaded through this network, enabling surgeons to directly 3D print their patients' protheses using titanium powders sourced from processed Australian rutile," Mr Ferris says.